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View the Newsletter
Fall 2014
The IRB Newsletter
University of Colorado - Boulder
Student Desire2Learn Course Debuts this Fall
By: Tracy Giordano
The long awaited Desire2Learn
student course will be released
this fall. The course is entering
the initial evaluation phase with
the expectation of becoming
available for use in mid to late
October. Faculty interested in
participating in the evaluation
period should contact either Tracy
Giordano or Claire Dunne for
acces to the Desire2Learn course.
About the course
As previously announced, this
course covers three important
aspects of student research: the
history of human research,
classroom projects, and
IRB-reviewed research. The entire
course takes 1 hour to complete
and includes two quizzes: a history
quiz and an IRB-reviewed quiz,
both based on the material
covered within its respective
module. The classroom project
and IRB-reviewed modules are
complementary and each address
the key charactersitics of each
type of research and provides
practical information the student
Submission Deadlines
The upcoming submission
deadlines for full board
review are:
October

Panel A:

Panel B:
November

Panel A:

Panel B:
December

Panel A:

Panel B:
September 29
October 9
October 27
November 6
November 24
December 4
Expedited and exempt
submissions will continue to be
reviewed on a rolling basis.
ADA
Compliance
and the IRB
By: Tracy Giordano
Preview of course history module in Desire2Learn.
can use to complete research
while staying within the bounds of
ethical requirements.
This Desire2Learn course is a
replacement for the Students in
Research course that was available
in the CITI program. Access can be
given to any CU student who has
an active Identikey. The course is
intended to provide supplemental
educational material for any CU
course that requires a review of
human research ethics. It is not,
however, a replacement for the
IRB required CITI training that
investigators and key personnel
must complete for any independent research conducted at CU.
This summer the IRB began a
department-wide initiative to
ensure the office and its
resources are compliant with
ADA accessibility laws. All
resources are being assessed
and converted. The initial effort
started with all electronic documents since these documents
are regularly used. The forms
and templates were the first
items to be offered in alternate
format; guidance documents
are next . The ADA compliant
versions also resolve any Mac
compatibility issues you may
have encountered in the past.
We greatly appreciate your
patience in this effort and welcome any questions or comments on this issue. Please feel
free to contact us via email at
[email protected] or you
may call Claire Dunne, the IRB
Program Director, at 303-7355014.
Prefer to use direct links? Check out the digital copy of the newsletter on
the IRB website — get the URL below!
IRB Workshops to Start in Late September
By: Tracy Giordano
This fall the IRB is coming out to
you! Whether you need help with
the eRA system or want an IRB
professional’s advice about your
submission documents, we are
here to help. There are currently
12 scheduled sessions that are
available on both the main and
east campus. Consult the
schedule located to the right to
see which sessions fit best with
your schedule.
Main Campus: Norlin Library,
1st Floor Commons, Rm 109
East Campus: Administrative
& Research Center, Rm A16
Time: 11AM-1PM
Monday, September 29
Monday, October 13
Monday, October 27
Time: 11AM - 1PM
Tuesday, September 30
Tuesday, October 14
Tuesday, October 28
Time: 12PM - 2PM
Wednesday, October 8
Wednesday, October 22
Wednesday, November 5
Time: 12PM -2PM
Thursday, October 9
Thursday, October 23
Thursday, November 6
http://www.colorado.edu/vcr/irb
The IRB Newsletter
Page 2
A Reminder About Faculty Advisor Review
By: Doug Grafel
All research submitted to the IRB
by CU students must be reviewed
and approved by a faculty advisor
before it is received by the IRB
office. This requirement applies to
all students conducting research
involving human subjects, whether
undergraduate or graduate student. The faculty advisor is a
critical link in the human subjects
protection chain. A student's
faculty advisor should be an experienced researcher themselves,
and is considered ultimately re-
sponsible for how the student
conducts their research. The faculty advisor should work with the
student to design and submit
study documents to the IRB, and
closely oversee the conduct of his
or her student's research. In eRA,
the advisor must review each
document submitted to the IRB to
ensure it is complete and accurate
in describing the research the
student will undertake. The advisor should return any problems
with the submitted documents to
the student for revision, and then
re-review before passing them on
to the IRB. As of October 2013,
faculty advisors began receiving
copies of determination letters
from the IRB. Advisors are asked
to review these letters, and work
with the students to complete any
needed modifications or updates
to a submission. Written and
video instructions for students
routing a submission, or advisors
completing reviews are on the IRB
website under Submit For IRB
Review > Submission Guides.
A Renewed Vision and Mission for the IRB
By: Tracy Giordano
In this new academic year, the IRB
is putting a fresh step forward
with a newly defined vision and
mission statement. This realignment is part of an overall Office of
Research Integrity initiative to
define departmental performance
business plans which incorporate
the core values that are important
to both leadership and staff.
Our Vision
Simply put, our vision is to provide the CU campus community
with quality service in regards to
ethical human research review.
Through knowledgeable and
respectful guidance our goal is to
offer you the assistance you need
throughout the submission and
review process.
Our Mission
In line with the vision, a new mission statement has been defined.
The new mission statement focuses on three key avenues: providing high quality guidance, providing timely turnaround review
times, and offering a user-friendly
interface for the electronic
submission system, eRA.
All projects taken on by the IRB
office will be a reflection of these
goals. Some examples are the
recent ADA accessibility initiative
and new interface upgrade we
have requested from the eRA
vendor. We sincerely thank you
for continued support.
If you would like to read the vision
and mission in its entirety, visit
the About Us section of the IRB
webite.
Contact Us
Dr. Joseph Rosse
Associate Vice Chancellor of Research Integrity &
Compliance
(303) 735-5809
[email protected]
Dr. Claire Dunne
IRB Program Director
(303) 735 –5014
[email protected]
Sasha Barajas
Panel B (Biomedical)
Coordinator
(303) 735-6652
[email protected]
Doug Grafel
Panel A (Social Behavioral)
Coordinator
(303) 492-1940
[email protected]
Tracy Giordano
Education & Training
Coordinator
(303) 735-3700
[email protected]
Institutional Review Board
3100 Marine Street
ARCE A15
563 UCB
Boulder, CO 80309
303-735-3702
[email protected]
IRB Website Improvements
CITI Training: RCR Doesn’t Count
By: Tracy Giordano
By: Doug Grafel
The IRB website has undergone a few changes to improve usability. In addition to a few
small cosmetic alterations on the homepage,
several categories have been renamed and
reorganized. Those that were renamed are
part of the Panel Member Resources: Reviewer Resources is now Worksheets &
Checklists, and Review Guides is eRA
Review Guides.
The most impactful change is the shift of the
Forms & Templates and Guidance Documents to the top level navigation. Although
Submission Packet was consistent with
other IRB communicaitons, your feedback
indicated that fewer clicks are better.
Category updates to improve
usability of the IRB website.
To help us to continue to improve, please
keep your feedback coming! We have created a new website experience survey to better
capture your response and give you the
opportunity to provide real-time
feedback about any usability issues you have
faced.
Investigators conducting human subjects research are required to complete training in human research ethics. CU Boulder accomplishes this
through the CITI program. There are two modules that meet this requirement: the Biomedical Research Investigators and Key Personnel
course or the Social Behavioral Research Investigators and Key Personnel course. It is critical that you are aware of which training modules
meet the IRB requirement because CU Boulder contracts with CITI for
other regulatory training modules including Laboratory Animal Use, Export Controls, and Responsible Conduct of Research (RCR). An easy way
to ensure you are completing the correct course is to look for the Human
Subjects Research (IRB) title when choosing your learner group.
Frequently, investigators only complete the RCR training. This training
does not cover the same information required for human research investigators, and will not be accepted in lieu of the IRB courses. Studies that
are submitted where key personnel have only completed the RCR training
will be returned without review, and will not be reviewed until the correct
training has been completed. More information and instructions for signing up for CITI Training are on the IRB website under Getting Started >
CITI Training.
If you have comments, questions or
concerns that you would like to share
with the IRB Office, please email us.
http://www.colorado.edu/vcr/irb
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